Sr Electronics Production Engineer

Johnson & Johnson-posted 11 days ago
$91,000 - $151,800/Yr
Full-time • Mid Level
Onsite • Danvers, MA
5,001-10,000 employees
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Sr. Electronics Production Engineer Purpose: This role will drive the scale-up and production of a complex electro-mechanical medical device used in life-saving cardiac support therapies. This role will own scale-up activities, validations, root-cause investigations, safety and regulatory compliance, and continuous process improvement with a focus on cost savings and robust, repeatable manufacturing processes.

  • Scale-Up & Design Transfer Lead scale-up from pilot to full-scale production, including process development, equipment qualification, line layout, and work instructions. Collaborate with R&D and Quality to ensure smooth design transfers and robust manufacturing readiness.
  • Validation & Verification Plan and execute IQ/OQ/PQ activities for equipment, processes, and software where applicable. Develop and approve validation protocols and reports; ensure traceability to user needs and regulatory requirements.
  • Root Cause Investigation & CAPA Lead root-cause analysis for yield loss, quality escapes, and process deviations using structured problem-solving methods. Implement corrective and preventive actions (CAPA), verify effectiveness, and close with data-driven evidence.
  • Safety & Regulatory Compliance Ensure manufacturing activities comply with EHS standards and device safety requirements. Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed.
  • Process Improvement & Cost Savings Identify and execute Lean/Six Sigma projects to improve throughput, reduce cycle times, increase yield, and lower cost per unit. Apply statistical methods (DOE, SPC, MSA, Cp/Cpk analysis) to optimize processes and sustain gains.
  • Quality Systems & Documentation Maintain and improve documentation: SOPs, work instructions, MBR/Device History Records, change controls, and validation artifacts. Develop and manage PFMEA, Control Plans, and ongoing quality checks to ensure product reliability.
  • Production Support Provide hands-on troubleshooting on the manufacturing floor; drive standard work, line balancing, and equipment optimization. Monitor key production metrics and implement actions to meet targets for quality, cost, and schedule.
  • Cross-Functional Collaboration Partner with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to align on program milestones, risk, and resource needs. Mentor and coach junior engineers and technicians; contribute to a culture of continuous improvement.
  • Bachelor’s degree in Engineering (Electrical, Mechanical, Biomedical, Industrial, or related).
  • 6–10+ years of manufacturing engineering experience in electronics or medical devices (device hardware, electronics assembly, or related fields).
  • Working knowledge of FDA QSR/21 CFR Part 820 and ISO 13485.
  • Experience supporting or leading design transfers, validation activities, and quality systems in a regulated environment.
  • Proficient in DOE/DOE-based experiments, statistical process control (SPC), capability analyses (Cp/Cpk), MSA, and root-cause analysis methodologies.
  • Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing.
  • Experience with change control, CAPA, PFMEA, control plans, and documentation management.
  • Excellent problem-solving, communication, and project-management skills.
  • Ability to work cross-functionally, influence without authority, and manage multiple priorities in a fast-paced environment.
  • Master’s degree strongly preferred.
  • Familiarity with PCB/SMT assembly, soldering, testing, electronics packaging, and related manufacturing processes.
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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